Cleared Traditional

DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED

K913302 · Carwild Corp. · General & Plastic Surgery

Jul 1992

Decision

364d

Days

Class 1

Risk

About This 510(k) Submission

K913302 is an FDA 510(k) clearance for the DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED, a Gauze/sponge, Internal, X-ray Detectable (Class I — General Controls, product code GDY), submitted by Carwild Corp. (Old Mystic, US). The FDA issued a Cleared decision on July 23, 1992, 364 days after receiving the submission on July 25, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4450.

Submission Details

510(k) Number	K913302 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 1991
Decision Date	July 23, 1992
Days to Decision	364 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement